Pharmacological GLP Toxicology Studies

All drug molecules are first subjected to pharmacology and toxicology studies to check their potential against the diseases and then set as commercial drugs. In pharmacy, the pharma companies formulate and design the verities of drugs. They cannot finalize those drugs for commercial use before determining the efficacy and safety at preclinical (non-clinical) and clinical levels.

According to the GLP, the drug manufactured by a company must also go through the safety procedures for animals and humans under controlled requirements.

• Preclinical studies, research, and practice are mandatory for every pharmaceutical drug.
• The GLP toxicology research or studies are performed to check the drug’s severity, dose, and efficacy of the drug with different doses.
• The drug checks out through different sources like oral intake, intravenous method, intramuscular, and so on.
• The preclinical GLP studies (nonclinical IND enabling studies) are performed on the animal models, like mice, rats, and rabbit minipigs, and then scientists compared the results and toxicity levels in all the animals.
• In toxicology studies, it is essential to study the chemistry of the drug, structure and physical characteristics, pathology, effect on cardiac, and so many factors are involved.

Purpose of Toxicology Studies

Even water is not pure nowadays; it may contain many harmful chemicals. Food may contain carcinogens, pests, and pathogens that can cause toxicity, and air has pollutants that humans inhale. These toxic substances may cause headaches, nausea, severe illness, cancer, or abnormality. To avoid these problematic circumstances, toxicology studies decrease the chemical injuries and help understand the test compound and toxic material’s nature. Scientists apply in vitro and in vivo GLP testing and molecular-based laboratory techniques to analyze toxicology risks of test articles, and therefore minimize the risks to the ecosystem and humans.

Kinds of Toxicology Studies

• Systematic toxicology studies
• Reproductive toxicology studies
• Local toxicology studies
• Hypersensitivity studies
• Genotoxicity studies
• Carcinogenicity studies

Systematic toxicology studies

These systematic toxicology studies determine or observe the toxicity of the substance or compound in the animal body, tissues, or organs. Systematic toxicology studies are further divided into two sub-types.

• Single dose studies
• Repeated dose studies

1. Single dose studies

The single-dose studies aim to check the effect of a compound. In this study, scientists check the adverse effect on animals after a single dose in the form of multiple little doses.

2. Repeated dose studies

The purpose of repeated dose studies is to check the toxicity after repeated administration at different time intervals.

Local toxicology studies

In the local toxicology studies, scientists observe the pharmacological compound or any substance effect on the skin or the eye. It is included in the general studies, and researchers determine the toxicity through the intravenous or single dose method.

Hypersensitivity studies

The experts evaluate or check which compound is causing infection, toxicity, or hypersensitivity in the body. Hypersensitivity is caused by the enhancement of the immune complexes and increases in any hormones that cause hypersensitivity. Any infection can also be the reason for it.

Carcinogenicity Studies

Pharmaceutical companies developed various compounds, and it is essential to check the carcinogenicity before applying them to humans. The medicine application needs to conduct a long-term clinical trial to monitor and rate efficacy.

Reproductive toxicology studies

In the reproductive toxicology studies, the researcher under GLP determines the candidate compound toxicity on the reproduction system of females and the fertility of males. Two reproductive toxicology studies are included (male fertility and female reproductive system):

Male fertility

The male toxicology studies are part of phases I and II before fertility studies. These studies were performed at early stages afterward the male fertility clinical performed which are included in phase III. Male reproductive organs researchers checked by using the repeated dose method.

Female reproductive system

Females who don’t have the childbearing ability or potential, for example, permanently sterilized women and postmenopausal females. These females are part of toxicology clinical trials without reproduction toxicity studies. The repeated dose studies implement on them.

Genotoxicity Studies

The human body contains billions of genes and 24 sets of chromosomes. Any toxic substance, compound, or chemical can cause genetic mutation. For human life, it is essential to promptly identify the toxicity of the single dost clinical trial for the gene mutation.

Toxicity

Before implementing any drug or any experiment, it is essential to test the toxicity of the chemical substance or any experiment. The ability to damage the organism is known as toxicity or poisonous.

Toxicology

Toxicology is the branch of science that measures or checks a substance’s effect, nature, and physical characteristics on an organism and the environment. These studies identify the different compounds and their toxicity profile.

Toxicology is a multidisciplinary field, and it is not specific. It expanded after observations and collecting the data from the different regions about aspects like pharmacy, medicines, epidemiology toxicity, and engineering regions. Scientists identify and check the quantity of toxic substances. Many toxic substances are also present in the surroundings due to human exposure like smoke, and polluted air, which introduce the hazards and cause different diseases.

Toxicology studies comprise three subdivisions.

• Environmental toxicology
• Economical toxicology
• Forensic toxicology

1. Environmental toxicology (Wikipedia)

Different harmful chemicals are the reason for environmental toxicology; their source is human beings. Various factors are involved, like humans throwing the plastic into the oceans and that plastic is toxic to marine life. Different exposure contaminates the food, air, and rain and causes acid rain. Carbon monoxide gases disturb the ozone layer and are toxic to the natural environment.

2. Economical Toxicology (Science)

Drug development companies are introducing food additives, insecticides, pesticides, and many more. These insecticides and pesticides minimize the number of insects and pests. It is economical toxicology. Reducing the number of other specie just for the benefit or sake of the other species is against economic rights. Many food additives are harmful in excess amounts, and some cause human diseases. These chemicals are economically toxic.

3. Forensic Toxicology (ScienceDirect)

The last subdivision is forensic toxicology. It deals with the medical fields that include the legal factors and impacts of harmful chemicals on humans. Scientists check the toxicity of drugs and the cause-effect relationship. In sports, players take drugs to enhance their toxic performance. Some chemical substances are poisonous to the biological fluid and tissues and can disturb the hormonal imbalance.

Read more:

• Toxicology services: IND-enabling studies
• Technology: Pharmacology and Toxicology
• Pharm/Tox products: Types of nonclinical studies